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EC number: 213-203-6 | CAS number: 929-59-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 24, 1985- April 4, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The study is well-documented and performed according to generally accepted scientific standards.
- GLP compliance:
- yes
- Test type:
- other: Dose range finding followed by a unique dose application.
- Limit test:
- yes
Test material
- Reference substance name:
- 3,6-dioxaoctamethylenediamine
- EC Number:
- 213-203-6
- EC Name:
- 3,6-dioxaoctamethylenediamine
- Cas Number:
- 929-59-9
- Molecular formula:
- C6H16N2O2
- IUPAC Name:
- 2-[2-(2-aminoethoxy)ethoxy]ethan-1-amine
- Test material form:
- liquid
- Details on test material:
- - Physical state: liquid
- Appearance: colourless liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 5601-49-1, J-243
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sgarlat's rabbitry, Harvey's Lake, Pennsylvania
- Age at study initiation: no data
- Weight at study initiation: 2 - 3 kg
- Fasting period before study: no data
- Housing: rabbits were individually housed in cages sized in accordance with the 'Guide for the Care and Use of Labratory Animals' of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): ad libitum, Waye Rabbit Ration
- Water (e.g. ad libitum): ad libitum, fresh tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h light/12 h dark
IN-LIFE DATES: From: March 21, 1985 To: April 4, 1985
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal trunk, abraded area.
- % coverage: No less than 20%
- Type of wrap if used: Gauze, followed by a rubber dam and wrapped with an ace bandage to retard evaporation.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wrappings were removed, no washing done.
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8.0 g/kg
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hrs
- Doses:
- 1, 3, 5 and 8 g/kg (dose range finding study)
8 g/kg (main study) - No. of animals per sex per dose:
- 1 male, 1 female (dose range finding)
5 males, 5 females (main study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes, 2 and 4 hours, and then twice daly through 14 days.
- Necropsy of survivors performed: yes, sacrificed by CO2 inhalation
- Other examinations performed: clinical signs, body weight, organ weights
Results and discussion
- Preliminary study:
- A dose-range-finding study was performed, consisting of 4 groups of two rabbits per group, dosed at 1.0, 3.0, 5.0 and 8.0 g/kg. No mortality was observed.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 8 other: g/kg
- Based on:
- test mat.
- Mortality:
- 3 out of 10 rabbits died during the study
- Clinical signs:
- other: Decreased activity, diarrhea, ptosis, decreased muscle tone, abnormal stance, dypsnea, poor grooming, necrosis and alopecia at the application site, bruxism, red exudate (anal-genital region) and prostration.
- Gross pathology:
- Necropsy of rabbits dying on study revealed hemorrhages of fascia underlying application site, edematous and congested lungs, pale kidneys, cortical necrosis of the kidneys, discolored ureter and fluid-filled bladder. Terminal necropsy of the surviving animals revealed hemorrhage of fascia and necrosis of skin underlying application site.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the observations made in the study, the estimated LD50 of the test material was determined to be greater than 8.0 g/kg. Therefore, the test substance is considered not to be classified according to CLP regulation .
- Executive summary:
In a dose-range-finding screen, four groups of two abraded rabbits per group (one male and one female) were administered the test article at 1.0 / 3.0 / 5.0 and 8.0 mg/kg. None of the rabbits died in the dose-range-finding study.
In an 8.0 mg/kg limit test, one group of ten rabbits (five males and five females) was dermally administered the test article.
Three of the animals died during the study. Signs observed included: decreased activity, diarrhea, ptosis, decreased muscle tone, abnormal gait, abnormal stance, dyspnea, poor grooming, necrosis and alopecia at the applicatio site, bruxism, red exudate (anal-genital region) and prostration.
Necropsy of the animals dying on study revealed hemorrhages of fascia underlying the application site, edematous and congested lungs, pale kidneys, cortical necrosis of the kidneys, discolored ureter and fluid-filled bladder.
Terminal necropsy of the surviving animals revealed hemorrhage of fascia and necrosis of skin underlying the application site.
Based upon the observations made in the definitive acute dermal toxicity study in rabbits, the estimated LD50 for the test article was determined to be greater than 8.0 mg/kg.
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